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Metronomic Vinorelbine in Patients With Metastatic Tumors: Phase II Translational Study

Phase 2
16 Years
75 Years
Not Enrolling
Breast Cancer, Non Small Cell Lung Cancer, Prostate Cancer

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Trial Information

Metronomic Vinorelbine in Patients With Metastatic Tumors: Phase II Translational Study

The purpose of this study is to define the biologically optimal dose of vinorelbine when
administered at a metronomic dosing schema. [Metronomic chemotherapy refers to the close,
regular administration of minimally toxic doses of cytotoxic drugs, with minimal or no
drug-free breaks, over prolonged periods]. Patients with recurrent or metastatic solid
tumors are randomly assigned one of three different doses of oral vinorelbine (30 or 40 or
50 mg). Treatment is administered three times a week (Monday, Wednesday and Friday)
continuously until disease progression or unacceptable toxicity or to a maximum of 24

Inclusion Criteria:

- Signed informed consent

- Ages 16 - 75 years

- Genders: both

- Performance status 0-2 according to the World Health Organization (WHO) scale

- Life expectancy of at least 16 weeks

- Adequate bone marrow, hepatic and renal functions

- Absence of brain metastasis

- Metastatic/locally advanced refractory prostate, breast or non-small cell lung cancer
previously treated with no more than two chemotherapeutic regimens

- White blood cells >= 3500/mm^3

- Absolute neutrophil count >= 1500/mm^3

- Platelets >= 100,000/mm^3

- Total serum bilirubin less than 1.5 mg/dl

- Serum transaminases less than 2.0 x upper normal limit (UNL) unless attributed to
liver metastases

- Serum creatinine within normal range

Exclusion Criteria:

- Major active infection

- More than two prior chemotherapy regimens for metastatic disease

- Any of the following within the 12 months prior to starting the study treatment:

- myocardial infarction,

- severe/unstable angina,

- coronary/peripheral artery bypass graft,

- congestive heart failure,

- cerebrovascular accident or transient ischemic attack, or pulmonary embolism,

- cardiac dysrhythmias of grade >/= 2,

- atrial fibrillation of any grade, or

- heart rate corrected interval (QTc) > 450 msec for males or > 470 msec for

- Hypertension that cannot be controlled with medications (> 150/100 mmHg despite
optimal medical therapy)

- Ongoing anti-coagulation therapy

- Pregnancy or breastfeeding

- Other severe acute or chronic medical or psychiatric condition, or laboratory
abnormality that would impart, in the judgment of the investigator, excess risk
associated with study participation or study drug administration; or which, in the
judgment of the investigator, would make the patient inappropriate for entry into the

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

time to treatment failure

Outcome Time Frame:

TTF rates per arm will be compared at 4 and 6 months

Safety Issue:


Principal Investigator

Evangelos Briasoulis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistant Professor of Oncology, Medical School, University of Ioannina


Greece: Ministry of Health and Welfare

Study ID:

HE 50/05



Start Date:

January 2006

Completion Date:

February 2008

Related Keywords:

  • Breast Cancer
  • Non Small Cell Lung Cancer
  • Prostate Cancer
  • Metronomic-therapy
  • vinorelbine
  • Recurrent Breast Cancer
  • Recurrent Non Small Cell Lung Cancer
  • Metastatic prostate cancer
  • Breast Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Prostatic Neoplasms